Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01167413
Recruitment Status : Unknown
Verified January 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2010
Last Update Posted : August 6, 2010
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:

Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the result of increased processing of pain by the central nervous system.

Axial spondyloarthropathy is the hallmark of Ankylosing Spondylitis (AS), an inflammatory joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints.

Although FMS and AS differ vastly in their pathogenesis, a considerable clinical overlap may exist between these conditions. Both disorders typically cause chronic nocturnal back pain and disturbed sleep may accompany either condition. In addition,the investigators have previously described an increased prevalence of (secondary) FMS among female AS patients.

This overlap may have important clinical implications since the presence of comorbid FMS may lead to increased severity results on commonly used instruments in the evaluation of disease activity in AS, such as the BASDAI and BASFI .

Recently, the Assessment of Spondyloarthritis international Society (ASAS) has published updated classification criteria for axial spondyloarthropathy. These criteria, which are summarized in table 1, are based on the evaluation of patients suffering from chronic back pain with an age of onset of less than 45.


The objective of the current study is to evaluate the prevalence of axial spondyloarthropathies among FMS patients, utilizing the new ASAS criteria.

Condition or disease Intervention/treatment
Fibromyalgia Ankylosing Spondylitis Device: Evaluation by manual Dolorimeter Other: SIJ imaging

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia - Application of the ASAS Classification Criteria
Study Start Date : August 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Group/Cohort Intervention/treatment
FIbromyalgia Patients
Patients diagnosed as suffering from Fibromyalgia according to the ACR criteria
Device: Evaluation by manual Dolorimeter
Patients will be examined by a manual Dolorimeter

Other: SIJ imaging
Patients will undergo imaging of the Sacroiliac joint by plain x-ray or MRI and sacroileitis will be documented

Primary Outcome Measures :
  1. Prevalence of Ankylosing Spondylitis as diagnosed according to ASAS criteria [ Time Frame: 1 month ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited consecutively from the Fibromyalgia clinic as well as the general rheumatological clinic of the Tel Aviv Sourasky medical center.

Inclusion Criteria:

Patients fulfilling American College of Rheumatology criteria for classification of Fibromyalgia:

  • Widespread pain lasting over three months
  • Tenderness in at least 11 of 18 points

Exclusion Criteria:

  • Patients with known inflammatory joint disease prior to the study
  • Patient not able to give informed consent
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01167413

Contact: Jacob N Ablin, MD 972-3-6973668

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Jacob N Ablin, MD Tel-Aviv Sourasky Medical Center

Responsible Party: Jacob Ablin, MD, Director, Fibromyalgia Clinic, Institute of Rheumatology, Tel Aviv Sourasky Medical Center Identifier: NCT01167413     History of Changes
Other Study ID Numbers: TASMC-10-JA-0423-CTIL
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Spondylitis, Ankylosing
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Joint Diseases